The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old … (NCT03384719) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
Denmark129 participantsStarted 2018-01-18
Plain-language summary
The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children
Who can participate
Age range
7 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 7-8 years
* Healthy\*
* The child is willing to consume protein powder twice a day for 4 weeks
* The child is not a picky eater and so does not mind trying new foods and flavours
* The child speaks Danish in order to understand the study procedures
* The parents read and speak Danish in order to be properly informed about the study procedures
* Written informed consent has been obtained
* The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved
Exclusion Criteria:
* The child drinks more than 350 ml of milk per day
* Known or suspected allergy, sensitization or intolerance to milk (protein or lactose), rapeseed or mustard
* Any acute illness\*
* Chronic illness or disease that may affect protein metabolism or growth\*
* Chronic intake of medicine that may affect protein metabolism or growth\*
* Concomitant participation in other studies involving dietary supplements or blood sampling
* Living in a household with another participating child
* The principal investigator, who is blinded to study tre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.